INSITE
In the study behind Lumisight's approval, scanning the lumpectomy cavity with a fluorescent dye found cancer left behind by standard surgery in about one patient in thirteen and spared some women a second operation, with few false signals but a modest hit rate on individual margins.
Overview
INSITE (NCT03686215; organisation id CL0007) was the Lumicell-sponsored prospective multicentre pivotal trial of pegulicianine fluorescence-guided surgery with the LUM Imaging System for residual cancer in the breast lumpectomy cavity, run with National Cancer Institute support at 14 US sites. Women with stage 0 to 3 breast cancer received 1.0 mg/kg intravenous pegulicianine before lumpectomy and were randomly assigned 10:1 to fluorescence-guided surgery or a control group; the randomisation existed to stop surgeons taking smaller than standard lumpectomies in anticipation of the imaging, not to provide a powered control arm for device performance. In the imaging group, additional cavity margins were excised wherever the dye signalled. The three coprimary endpoints were the percentage of patients whose guided margins contained cancer, per-margin sensitivity and per-margin specificity.
In the NEJM Evidence 2023 report, 406 patients received pegulicianine and 392 were randomised (316 invasive, 76 in situ cancers). Among 357 patients who had fluorescence-guided surgery, guided margins removed tumour left behind after standard lumpectomy in 27 (22 from cavity orientations that standard margin evaluation had called negative). Second surgeries were avoided in 9 of 62 patients with positive margins. Per-margin specificity was 85.2 percent and sensitivity 49.3 percent. Pegulicianine was stopped for adverse events in six patients, and two had grade 3 serious adverse events related to it. The trial met its prespecified thresholds for residual tumour removal and specificity but not for sensitivity.
The FDA approved pegulicianine (Lumisight) in April 2024 as an adjunct for intraoperative detection of residual cancer after lumpectomy. ClinicalTrials.gov lists the trial as a completed phase 3 with 406 participants, matching the paper's treated cohort.
- Pegulicianine fluorescence-guided surgery: 27 patients.
- 85.2 out of 100 people reached this endpoint with Pegulicianine fluorescence-guided surgery.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- 49.3 out of 100 people reached this endpoint with Pegulicianine fluorescence-guided surgery.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- Pegulicianine fluorescence-guided surgery: 9 patients.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Stage 0 to 3 breast cancer undergoing lumpectomy: intravenous pegulicianine 1.0 mg/kg followed by fluorescence imaging of the cavity with the LUM Imaging System after standard excision, with extra margins taken where the dye signals. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
406 enrolled.
27 of 357 (about 7.6%); 22 from cavity orientations called negative on standard margin evaluation; met the prespecified threshold
SourceMet the prespecified threshold; the abstract does not give the margin denominator
SourceDid not meet the prespecified threshold
Source9 of 62 patients with positive margins
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Patients in whom fluorescence-guided margins removed residual cancer after standard lumpectomyprimary | Pegulicianine fluorescence-guided surgery | 357 | 27 patients | - | - | link |
| Per-margin specificityprimary | Pegulicianine fluorescence-guided surgery | - | 85.2% | - | - | link |
| Per-margin sensitivityprimary | Pegulicianine fluorescence-guided surgery | - | 49.3% | - | - | link |
| Second surgeries avoided among patients with positive margins | Pegulicianine fluorescence-guided surgery | 62 | 9 patients | - | - | link |
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